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Completed

NCT Number: NCT01631097

A Single-Dose Study of Tivozanib in Subjects With Hepatic Impairment and Normal Hepatic Function

This Phase 1, open-label, single dose study is designed to evaluate the pharmacokinetics, safety and tolerability of a single 1.5 mg tivozanib dose in subjects with varying degrees of hepatic impairment and normal hepatic function.

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Key information

Conditions

Hepatic Impairment

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Miami, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • BMI between 18 to 38 kg/m2
  • diagnosis of chronic or stable hepatic insufficiency, with a Child-Pugh classification scores of mild, moderate or severe.

Exclusion criteria

  • Current or previous history of hepatic carcinoma, hepatorenal syndrome, portacaval shunt surgery, significant hepatic encephalopathy, severe ascites, or pleural effusion
  • Currently undergoing dialysis
  • Poor peripheral venous access
  • Pregnancy or lactation

Treatment and study plan

Tivozanib hydrochloride

Drug

Single oral capsule 1.5 mg tivozanib hydrochloride

Primary outcomes

  1. Maximum Observed Concentration (Cmax)

    Time frame: pre-dose, 1, 3, 5, 7, 10, 12, 18, 24, 36, 48, 96, 168, 336, and 504 hours postdose

  2. Time to maximum concentration (Tmax)

    Time frame: pre-dose, 1, 3, 5, 7, 10, 12, 18, 24, 36, 48, 96, 168, 336, and 504 hours postdose

  3. Area under the concentration-time curve from Hour 0 to the last measurable concentration (AUC0 t)

    Time frame: pre-dose, 1, 3, 5, 7, 10, 12, 18, 24, 36, 48, 96, 168, 336, and 504 hours postdose

  4. Area under the concentration-time curve extrapolated to infinity (AUC0-∞)

    Time frame: pre-dose, 1, 3, 5, 7, 10, 12, 18, 24, 36, 48, 96, 168, 336, and 504 hours postdose

  5. Apparent terminal elimination rate constant (λz)

    Time frame: pre-dose, 1, 3, 5, 7, 10, 12, 18, 24, 36, 48, 96, 168, 336, and 504 hours postdose

  6. Apparent terminal elimination half-life (t1/2)

    Time frame: pre-dose, 1, 3, 5, 7, 10, 12, 18, 24, 36, 48, 96, 168, 336, and 504 hours postdose

  7. Apparent total clearance (CL/F)

    Time frame: pre-dose, 1, 3, 5, 7, 10, 12, 18, 24, 36, 48, 96, 168, 336, and 504 hours postdose

  8. Apparent volume of distribution (Vz/F)

    Time frame: pre-dose, 1, 3, 5, 7, 10, 12, 18, 24, 36, 48, 96, 168, 336, and 504 hours postdose

Secondary outcomes

  1. Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: up to 16 weeks

  2. Change from baseline in vital signs

    Time frame: Baseline and End of Study Visit (Day 30)

  3. Change from baseline in physical examinations

    Time frame: Baseline and End of Study Visit (Day 30)

  4. Change from baseline in hematology including coagulation assessments

    Time frame: Baseline and End of Study Visit (Day 30)

  5. Change from baseline in chemistry assessments

    Time frame: Baseline and End of Study Visit (Day 30)

  6. Change from baseline in urinalysis assessments

    Time frame: Baseline and End of Study Visit (Day 30)

  7. Change from baseline in thyroid function tests

    Time frame: Baseline and End of Study Visit (Day 30)

  8. Change from baseline in electrocardiograms

    Time frame: Baseline and End of Study Visit (Day 30)

Sponsors and collaborators

Lead sponsor

AVEO Pharmaceuticals, Inc.

Industry

Registry information

Official study title

A Phase 1, Open-label, Single Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Tivozanib in Subjects With Hepatic Impairment and Normal Hepatic Function

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jun 28, 2012
Registry last updated
Jan 27, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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